In pharmacovigilance, cases or reports of adverse drug reactions (ADRs) and other drug-related problems can originate from various sources. Here are the primary sources of cases in pharmacovigilance
3. INTRODUCTION
SOURCES OF SAE REPORTS
SAE reports will be received from the Unsolicited source, Solicited
source, Contractual agreements and Regulatory authorities.
SOURCES
UNSOLICITEDSOURCE
SOLICITEDSOURCE
CONTRACTUAL
AGGREMENTS
REGULATORYAUTHORITIES
4.
5. UNSOLICITEDREPORTS
DEFINITION
Unsolicited report is not expressly requested by a person and is
produced for them without their permission. Unsolicited is something
proposed to a client/customer and they did not ask for it.
Unsolicited
reports
Spontaneous
report
Literature
reports
Internet reports
Othersources
6. Spontaneous reports
A spontaneous report is unsolicited communication by a healthcare professional or
consumer to a competent authority, marketing authorization holder or other
organization that describes one or more suspected adverse reactions in a patient
who was given one or more medicinal products and that does not derive from a
study or any organized data collection systems where adverse events reporting is
actively sought.
7. Literature reports
Each MAH is expected to regularly screen the worldwide scientific literature by
accessing widely used systemic literature reviews or reference databases. Cases of
ADRs from the scientific and medical literature, including relevant published
abstracts from meetings and draft manuscript, might qualify for expedited
reporting. A regulatory reporting form with relevant medical information should
be provided for each identifiable patient. The publication references should be
given as the report source.
8. Internet reports
These reports are received from websites
under their management for potential ADR
case reports. Unsolicited cases from the
internet should be handled as spontaneous
repots. For the determination of
reportablity, the same criteria should be
applied for this cases.
Other sources
Aware of case report from non-medical sources, e.g. the lay press or other
media, it should be handled as a spontaneous report. For determination of
reportablity, the same criteria should be applied as for other reports.
9. SOLICITEDREPORTS
DEFINITION
Derived from organized data collection systems (which include clinical trials,
post-approval named patient, other patient support and discharge management
programs, surveys of patients or healthcare providers, or information gathering
on efficacy or patient compliance )
Solicited
reports
Clinicaltrialcase
DRA
Pharmaceutical
companies
Patient
support
programs
10. Organized data collection systems SOCILITED
SOURCES
Post-approval
programs,
Surveys
Registries
Clinical trials
12. The marketing of many medicines increasingly takes place through
contractual agreements b/n 2/more companies.
Agreements vary comparably with respect to inter-company and
regulatory responsibilities.
It is very important to explicit contractual agreements specify the
processes for the exchange of safety information, including timelines etc.
Whatever the nature of arrangement, the MAH s ultimately responsible
for regulatory reporting.
Therefore, every reasonable effort should be made between the
contracting partners to minimize data exchange so as to promote
compliance with MAH responsibilities.
13. REGULATORY AUTHORITY SOURCES
Individual serious unexpected adverse drug reports
originatingfromRAs are subjectto othersby MAH
Re-submission of serious ADR cases without new
information to the originating RA is not usually
necessary unless otherwise specified by local
regulations
